CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

+ [1]

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesNeoplasms+ [1]

Active Indication-

Inactive Indication

CD20 Positive B-Cell Non-Hodgkin LymphomaDiffuse Large B-Cell LymphomaRheumatoid Arthritis

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization-

Inactive Organization

Teva Branded Pharmaceutical Products R&D, Inc.

Teva Pharmaceutical Industries Ltd.

Lonza Group AG

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 83181H

The sequence is quoted from: *****

Sequence Code 27145L

The sequence is quoted from: *****

Clinical Trials associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

NCT01205737

/ CompletedPhase 1

A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.

Start Date01 Sep 2010

Sponsor / Collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

NCT01123070

/ CompletedPhase 1

A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis

The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.

Start Date05 Feb 2010

Sponsor / Collaborator

Teva Pharmaceutical Industries Ltd.

100 Clinical Results associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

100 Translational Medicine associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

100 Patents (Medical) associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

Literatures (Medical) associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

01 Oct 2023·Current Drug Delivery

Pharmaceutical Considerations of Translabial Formulations for Treatment of Parkinson’s Disease: A Concept of Drug Delivery for Unconscious Patients

Article

Author: Tiwari, Gaurav ; Tiwari, Ruchi ; Kaur, Arshpreet

Purpose:The goal of the present research was to isolate a biopolymer from Phaseolus vulgaris (P. vulgaris) and Zea mays (Z. mays) plants and used it to construct Resveratrol (RES)-loaded translabial films.Methods:Biopolymers were extracted from P. vulgaris and Z. mays seeds using a simple process. Separated biopolymers, sodium carboxymethylcellulose (SCMC) and tragacanth were subjected to formulation development by incorporating RES-loaded translabial films. The Fourier-transform infrared spectroscopy (FTIR), physical appearance, weight, thickness, folding endurance, swelling index, surface pH, percent moisture absorption, percent moisture loss, vapor transfer rate, and content uniformity of the translabial films were examined. The mucoadhesive, ex-vivo permeation, in vivo and stability studies, were performed.Results:The results showed that RES-loaded translabial films produced from P. vulgaris and Z. mays biopolymers exhibited exceptional mucoadhesive, stability, and permeation properties. Results revealed that the best formulations were prepared from a combination of biopolymer (P. vulgaris C or Z. mays C) with tragacanth. Formulations with tragacanth revealed good swelling and thus permeation profiles. In vivo release of TL 11 was found to be 24.05 ng/ml in 10 hours and it was stable enough at 45oC.Conclusion:This research suggested that RES-loaded translabial formulations can be potentially used for the treatment of Parkinson’s disease with good patient compliance to geriatric and unconscious patients.

News (Medical) associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

07 Dec 2022

·www.biospace.com

Accord Healthcare Adds Generic Drug for Use in Treating Leukemia and Non-Hodgkin's Lymphoma

Bendamustine Lyo. Injection joins Accord's portfolio of chemotherapy drugs DURHAM, N.C., Dec. 7, 2022 /PRNewswire/ -- Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Bendamustine Lyo. Injection to its line of chemotherapy drugs. Accord's product is AP rated to Teva's Treanda® and is being offered in both 25-mg and 100-mg vials. Bendamustine Lyo. Injection is in a class of medications called alkylating agents1. It works by killing existing cancer cells and limiting the growth of new cancer cells. Bendamustine is indicated for the treatment of adults with chronic lymphocytic leukemia (CLL) or indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or rituximab containing regimen. "Adding Bendamustine Lyo. Injection to our line of available chemotherapy drugs is an important step in continuing to make oncology therapies more accessible to those who need them," said Accord Healthcare President Jeff Hampton. "The availability of generics expands medication options for patients. When pharmacists have access to additional manufacturers, they are able to offer needed oncology products at a lower cost." Important Safety Information: Adverse reactions2 of Bendamustine Injection during infusion and within 24 hours post infusion may include nausea and fatigue (frequency >5%). Other adverse reactions can include myelosuppression, infections, anaphylaxis, tumor lysis syndrome, and skin reactions. The most common non-hematologic adverse reactions for CLL are pyrexia, nausea, and vomiting. The most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.2 Further information about safety and potential side effects can be found on the Products page at Accord Healthcare US. Bendamustine was approved3 by the US Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) in March 2008 and for the treatment of rituximab-refractory, indolent B-cell non-Hodgkin lymphoma (NHL) in October 2008. About Accord Healthcare US Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company. Accord is committed to improving lives by increasing access to medicines while also providing novel solutions that enhance the pharmaceutical experience for both healthcare providers and patients. Accord Healthcare combines its advanced manufacturing technology with in-house research to produce highly complex, affordable, and essential medicines. Accord Healthcare's forward-thinking, innovative approach, and its resolve to help patients remains at the heart of everything they do. Accord is headquartered in Durham, North Carolina. The Intas network markets its products in 80 countries. To learn more, visit the Accord website. REFERENCES: 1 Bendamustine Injection, Medline Plus. National Library of Medicine. Available at: . Accessed November 2022. 2 Drugs@FDA. U.S. Food & Drug Administration. Prescribing information. Available at: . Accessed November 2022. 3 Bendamustine for the treatment of chronic lymphocytic leukemia and rituximab-refractory, indolent B-cell non-Hodgkin lymphoma. Clin Ther. 2009. National Library of Medicine. Available at: . Accessed November 2022. Media Contact: Kellyann Zuzulo 215-287-7291 350167@email4pr.com

Drug Approval

29 Apr 2020

·www.biospace.com

Following Ruling, Teva’s Cancer Drug Bendeka Protected From Generics Until 2031

Shares of Eagle Pharmaceuticals and Teva Pharmaceuticals are climbing following a favorable ruling in U.S. District Court that protects the patent for cancer drug Bendeka from generic competition through 2031. Bendeka will not enter generics category until 2031. Shares of Eagle Pharmaceuticals and Teva Pharmaceuticals are climbing following a favorable ruling in U.S. District Court that protects the patent for cancer drug Bendeka from generic competition through 2031. A federal judge upheld Teva and Eagle’s 2017 patent claims that generic versions of the cancer treatment infringed on at least four separate patents for Bendeka (bendamustine hydrochloride injection, or bendamustine HCl), which was approved in 2015 for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. In the ruling, the court upheld the asserted patent claims made by Eagle and Teva, which licensed the drug from the smaller pharma company. Additionally, the judge ruled that the Abbreviated New Drug Applications filed by generic drugmakers Slayback Pharma LLC, Apotex Inc. and Apotex Corp., Fresenius Kabi USA and Mylan infringe upon those patents and as such, their products are barred from launching until 2031. In his ruling, U.S. District Court Judge Colm Connolly said the claims made by the generic drugmakers are invalid. “Although the evidence of commercial success does not support a finding of nonobviousness, I still find that defendants have not shown by clear and convincing evidence that the prior art they cited would have motivated a person of skill in the art to reach the claimed formulations,” Connolly wrote in his opinion, according to a report from Bloomberg . The patents in question cover the formulation of Bendeka, as well as the administration of the medication. The formulation patients are not set to expire until 2031 and the administration patents expire in 2033, Bloomberg reported, citing the U.S. Food and Drug Administration ’s registry of information on approved drugs. Eagle Pharma Chief Executive Officer Scott Tarriff said he was happy with the ruling that protects the “longevity” of Bendeka. “With this decision, Bendeka’s value is likely to be intact for many years, thus ensuring our continued ability to invest in our growing research program and product pipeline,” Tariff said in a statement. Bendeka has earned more than $2 billion since its launch. Kelley Dougherty, a spokesperson for Teva, told Bloomberg the company is pleased with the court’s decision that upholds the validity of its patents. Dougherty added the company will continue to focus on providing Bendeka to the patients who need it.

Drug ApprovalPatent Infringement

17 Feb 2015

·www.biospace.com

Eagle Pharmaceuticals, Teva Pharmaceutical Industries Forge $120 Million Leukemia Drug Pact

February 17, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor Israeli company Teva Pharmaceutical Industries Ltd. announced Tuesday that it has entered into a $120 million licensing agreement that will allow it to distribute and promote a competitor to its own cancer drug, Eagle Pharmaceuticals ‘s EP-3102. The news pushed Eagle ’s stock up over 13.8 percent in morning trading Tuesday. Eagle ’s non-Hodgkin’s lymphoma drug EP-3102 competes directly with Teva ’s Treanda, because both drugs target chronic lymphocytic leukemia. However, because EP-3102 is delivered via infusion, it is easier and faster to administer. The two companies said they will now settle a patent infringement lawsuit that had been brewing between them in U.S. District Court for the District of Delaware . Under the terms of the deal, Teva will shell out $30 million in cash, which will be followed by $90 million in additional milestone payments and double- digit royalties on sales. Teva will handle all regulatory approvals and both the costs and logistics associated with running clinical trials. “With a substantially shorter infusion time [than Treanda], Eagle ‘s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers,” said Paul Rittman , vice president of oncology, in a statement. Teva also said Tuesday it will now waive its orphan-drug exclusivities for two diseases that EP-3102 also targets, a move which will put it in front of consumers much more quickly. Eagle already has submitted a new drug application for EP-3102, a rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, to the U.S. Food and Drug Administration (FDA) . Because of its efficacy in clinical trials, it had requested priority review, a nice boost for a product which has already received orphan-drug designation the seven years of patent exclusivity that go with that demarcation. Separately, the companies said they will settle a pending patent-infringement action between them in the U.S. District Court for the District of Delaware . “We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff , president and CEO of Eagle Pharmaceuticals . “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.” BioSpace Temperature Poll Will Job Cuts Continue? After a week that saw Quintiles , Sanofi and Actavis slashing almost a 1,000 biotech jobs, BioSpace wonders if the ax will continue to fall. Give us your thoughts about the sector’s “streamlining” below. var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-hiring-heat-up-in-2017", placeholder: "pd_1423869348" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

License out/inPriority ReviewOrphan DrugPatent Infringement

100 Deals associated with Rituximab biosimilar(Teva Pharmaceutical Industries Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 3	Poland	Teva Branded Pharmaceutical Products R&D, Inc.	01 Sep 2010
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 3	Russia	Teva Branded Pharmaceutical Products R&D, Inc.	01 Sep 2010
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 3	Estonia	Teva Branded Pharmaceutical Products R&D, Inc.	01 Sep 2010
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 3	Hungary	Teva Branded Pharmaceutical Products R&D, Inc.	01 Sep 2010
Diffuse Large B-Cell Lymphoma	Phase 3	-	Lonza Group AG	-
Diffuse Large B-Cell Lymphoma	Phase 3	-	Lonza Group AG	-
Rheumatoid Arthritis	Phase 3	-	Teva Pharmaceutical Industries Ltd.	-
Rheumatoid Arthritis	Phase 3	-	Lonza Group AG	-
Rheumatoid Arthritis	Phase 3	-	Teva Pharmaceutical Industries Ltd.	-
Rheumatoid Arthritis	Phase 3	-	Lonza Group AG	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01123070 (CTgov)	Phase 1	Rheumatoid Arthritis	54	TL011 (Double Blind TL011 1000 mg)	ifjzwldqtq(fthkztsknu) = lqcdtuvbyv mungjjeins (mctypzfvid, qylmnitypd - ygtpirjlxb) View more	-	04 Oct 2021
				MabThera (Double Blind MabThera 1000 mg)	ifjzwldqtq(fthkztsknu) = jzcdpcedkz mungjjeins (mctypzfvid, xroczpifde - occffncppx) View more
ASCO2021	Not Applicable	Chronic Lymphocytic Leukemia First line	201	Rituximab	jdybhpwswj(lhmbzxgsll) = kvcknksujw exepjugsxj (bybvevemop ) View more	-	28 May 2021
				Rituximab-abbs	jdybhpwswj(lhmbzxgsll) = ggtmpinbwf exepjugsxj (bybvevemop ) View more

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